DEVICE: United Hip System, U2 Bipolar Implant (04712771494372)
Device Identifier (DI) Information
United Hip System, U2 Bipolar Implant
1503-3255
In Commercial Distribution
1503-3255
UNITED ORTHOPEDIC CORP.
1503-3255
In Commercial Distribution
1503-3255
UNITED ORTHOPEDIC CORP.
U2 Bipolar Implant, 32mm I.D., 55mm O.D.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
33695 | Bipolar femoral head outer component, hemiarthroplasty |
An implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K101670 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 55 Millimeter |
Lumen/Inner Diameter: 32 Millimeter |
Device Record Status
dfaeff85-8470-4c85-9bbe-5d73ef431c47
September 09, 2020
5
October 24, 2015
September 09, 2020
5
October 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+886229294567
service@uoc.com.tw
service@uoc.com.tw